Efficacy of different doses of oliceridine for Patient-Controlled Intravenous Analgesia in patients undergoing Total Laparoscopic Hysterectomy.

Abstract

To evaluate the efficacy and safety of three oliceridine different doses for oliceridine for patient-controlled analgesia (PCIA) in patients undergoing during total laparoscopic hysterectomy, following the premature termination of the planned sufentanil control arm. This prospective, randomized, double-blind trial was originally designed as a four-arm study. Due to operational challenges in patient recruitment and randomization within the single-center setting-specifically, significant reluctance among eligible patients to be randomized to receive a traditional opioid regimen when oliceridine was available, leading to unsustainable enrollment timelines-the sufentanil control arm was prematurely terminated. The final analysis therefore focused on three oliceridine doses: 0.1, 0.35, and 0.5 mg/kg, diluted to 100 ml with normal saline for 48-hour PCIA. The primary endpoint for sample size calculation was the incidence of postoperative nausea and vomiting (PONV) at 24 h. Efficacy and safety outcomes analyzed included: NRS pain scores (at rest and during cough), Ramsay sedation scores, incidence of rescue analgesia, various recovery indicators (time to first flatus, time to ambulation, QoR-15 scores), and opioid-related adverse events. Compared to the low-dose group, the moderate- and high-dose groups demonstrated significant improvements in cough-pain scores and bolus press attempts ("Bolus press attempts" were defined as the total number of patient-initiated demands for a supplemental dose, including attempts made within the lockout interval) (p < 0.0083). Further comparison revealed that the moderate-dose group showed the best recovery outcomes, including shorter time to first flatus and ambulation, and higher QoR-15 scores. In contrast, although the high-dose group provided more potent analgesia, it was associated with a higher incidence of nausea, delayed flatus, and a significantly lower quality of recovery (QoR-15) score at 48 hours postoperatively compared to the moderate-dose group (p < 0.0083). Within the investigated PCA oliceridine dose range, the 0.35 mg/kg dose promotes early recovery in patients undergoing laparoscopic total hysterectomy through effective analgesia and reduced nausea, representing the best balance between efficacy and safety among the tested oliceridine-specific regimens.